Narcotic Drugs Prescription Ordinance)

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Ordinance on the Prescription, Dispensing and Proof of the Disposition of Narcotic Drugs (Narcotic Drugs Prescription Ordinance)

Verordnung über das Verschreiben, die Abgabe und den Nachweis des Verbleibs von Betäubungsmitteln (Betäubungsmittel-Verschreibungsverordnung - BtMVV)

Narcotic Drugs Prescription Ordinance of 20th January 1998 (BGBl. I p. 74 , 80), last amended by Article 3 of the Law of 15th July 2009 (BGBl. I p. 1801)

The Ordinance was issued as Article 3 V 2121-6-24/4 of 20th January 1998 I 74 (BtMÄndV) by the Federal Government with the consent of the Bundesrat. It entered into force on 1st February 1998 according to Article 6 sentence 1.

Section 1 Principles

(1) The narcotic drugs specified in Annex III to the Narcotics Act may be prescribed only as preparations. The provisions of this Ordinance shall also apply to the salts and molecular com- pounds of the narcotic drugs that are applied according to the state of medical science by physicians, dentists and veterinarians. Unless otherwise provided for in individual cases, the maximum quantity stipulated for a narcotic drug shall also apply to its salts and molecular com- pounds.

(2) Narcotic drugs for a patient or an animal and required for a physician's, dentist's or veterinarian's surgery shall only be dispensed upon presentation of a completed narcotic drugs prescription (prescription), those required for a hospital ward, only upon presentation of a completed narcotic drugs requisition form (ward prescription).

(3) Consistent evidence of the disposition and stock of narcotic drugs shall be kept in pharmacies, veterinary dispensaries, in surgeries of physicians, dentists or veterinarians, at the wards of hospitals or animal hospitals, in facilities of emergency services, the facilities specified in section 5 subsection 9b as well as on merchant ships flying the Federal flag.

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Section 2 Prescribing by a physician

(1) For one patient, a physician may prescribe within a period of 30 days: a) up to two of the following narcotic drugs, adhering to the maximum quantities determined below:

1. Amphetamine 600 mg 2. Buprenorphine 800 mg 2a. (deleted) 3. Codeine as a substitute drug 40,000 mg 3a. Diamorphine 30,000 mg 4. Dihydrocodeine as a substitute drug 40,000 mg 5. Dronabinol 500 mg 6. Fenetyllin 2,500 mg 7. Fentanyl 500 mg 8. Hydrocodone 1,200 mg 9. Hydromorphone 5,000 mg 10. Levacetylmethadol 2,000 mg 11. Levomethadone 1,500 mg 12. Methadone 3,000 mg 13. Methylphenidate 2,000 mg 14. (deleted) 15. Morphine 20,000 mg 16. Opium, standardized 4,000 mg 17. Opium extract 2,000 mg 18. Tincture of opium 40,000 mg 19. Oxycodone 15,000 mg 20. Pentazocine 15,000 mg 21. Pethidine 10,000 mg 22. (deleted) 23. Piritramide 6,000 mg 24. Tilidine 18,000 mg

- 3 - b) one of the other narcotic drugs specified in Annex III to the Narcotics Act except alfentanil, cocaine, etorphine, remifentanil, and sufentanil.

(2) In well-founded individual cases and observing the necessary security of the trade in narcotic drugs, the physician may deviate from the provisions of subsection 1 for a patient who is in his/her long-term care with regard to

1. the number of narcotic drugs prescribed and 2. the maximum quantities determined.

Such a prescription shall be marked with the letter "A".

(3) For the supply of his/her surgery, the physician may prescribe the narcotic drugs listed in subsection 1, as well as alfentanil, cocaine for interventions on the head, in the form of a solution with a content of up to 20 per cent or in the form of an ointment with a content of up to 2 per cent, remifentanil and sufentanil up to the quantity of his/her average fortnightly supply, but at least the smallest package unit. The stock kept of each narcotic drug shall not exceed the physician's monthly supply. The physician may prescribe diamorphine in quantities up to his/her average monthly supply. The stock kept of diamorphine shall not exceed the physician's average two-monthly supply.

(4) Only the physician who is in charge of a hospital or a unit of a hospital or who is supervising it in the absence of the physician in charge may issue prescriptions for the supply of hospital wards. He/she may prescribe the narcotic drugs specified in subsection 3, observing the limitations in terms of intended use, content, and dosage form determined therein. This also applies to a non-hospital physician who has a contractual arrangement for the hospitalization of his/her patients if the beds assigned to him/her are separated physically and organizationally from those in other units.

Section 3 Prescribing by a dentist

(1) For one patient, a dentist may prescribe within 30 days: a) one of the following narcotic drugs, adhering to the maximum quantities determined below:

1. Buprenorphine 40 mg

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2. Hydrocodone 300 mg 3. Hydromorphone 1,200 mg 4. Levomethadone 200 mg 5. Morphine 5,000 mg 6. Oxycodone 4,000 mg 7. Pentazocine 4,000 mg 8. Pethidine 2,500 mg 9. Piritramide 1,500 mg 10. Tilidine 4,500 mg

or b) one of the other narcotic drugs specified in Annex III to the Narcotics Act except alfentanil, amphetamine, cocaine, diamorphine, dronabinol, etorphine, fenetyllin, fentanyl, levacetylmethadol, methadone, methylphenidate, nabilon, normethadone, opium, papaver somniferum, pentobarbital, remifentanil, secobarbital and sufentanil.

(2) For the supply of his/her surgery, the dentist may prescribe the narcotic drugs listed in subsection 1, as well as alfentanil, fentanyl, remifentanil and sufentanil up to the quantity of his/her average fortnightly supply, but at least the smallest package unit. The stock kept of each narcotic drug shall not exceed the dentist's monthly supply.

(3) Only the dentist who is in charge of a hospital or of a unit of a hospital or who is supervising it in the absence of the dentist in charge may issue prescriptions for the supply of hospital wards. He/she may prescribe the narcotic drugs specified in subsection 2, in compliance with the limitations determined therein concerning intended use, content, and dosage form. This also applies to a non-hospital dentist who has a contractual arrangement for the hospitalization of his/her patients if the beds assigned to him/her are separated physically and organizationally from those in other units.

Section 4 Prescribing by a veterinarian

(1) For one animal, a veterinarian may prescribe within a period of 30 days: a) one of the following narcotic drugs, adhering to the maximum quantities specified below: 1. Amphetamine 600 mg 2. Buprenorphine 150 mg

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3. Hydrocodone 1,200 mg 4. Hydromorphone 5,000 mg 5. Levomethadone 750 mg 6. Morphine 20,000 mg 7. Opium, standardized 12,000 mg 8. Opium extract 6,000 mg 9. Tincture of opium 120,000 mg 10. Pentazocine 15,000 mg 11. Pethidine 10,000 mg 12. Piritramide 6,000 mg 13. Tilidine 18,000 mg or b) one of the other narcotic drugs specified in Annex III to the Narcotics Act except alfentanil, cocaine, diamorphine, dronabinol, etorphine, fenetyllin, fentanyl, levacetylmethadol, methadone, metaqualone, methylphenidate, nabilone, oxycodone, papaver somniferum, pentobarbital, remifentanil, secobarbital, and sufentanil.

(2) In well-founded individual cases and observing the necessary security of the trade in narcotic drugs, the veterinarian may deviate from the provisions of subsection 1 with regard to

1. the number of narcotic drugs prescribed and 2. the maximum quantities specified in a particularly serious case of illness. Such a prescription shall be marked with the letter "A".

(3) For the supply of his/her surgery, the veterinarian may prescribe the narcotic drugs listed in subsection 1, as well as alfentanil, cocaine, for the purpose of local anesthesia for interventions on the head and in the form of a solution with a content of up to 20 per cent or in the form of an ointment with a content of up to 2 per cent, etorphine only for the immobilisation of animals kept in a zoo, a circus or in game enclosures, when administered by or in the pres- ence of the prescriber, fentanyl, pentobarbital, remifentanil and sufentanil up to the quantity of his/her average fortnightly supply, but at least the smallest package unit. The stock kept of each narcotic drug shall not exceed the veterinarian's monthly supply.

(4) Only the veterinarian in charge of an animal hospital or a unit of an animal hospital or who is supervising it in the absence of the veterinarian in charge may prescribe narcotic drugs for the supply on the ward. He/she may prescribe the narcotic drugs specified in subsection 3,

- 6 - except etorphine, observing the limitations in terms of intended use, content, and dosage form determined therein .

Section 5 Prescribing for substitution purposes

(1) For the purposes of this Ordinance, substitution shall be the application of a narcotic drug (substitute drug) prescribed by a physician, in an opiate-dependent patient, to

1. treat his/her opiate dependence in a way that seeks to gradually restore the individual’s abstinence from narcotic drugs, and also to improve and stabilise his/her state of health;

2. support the treatment of a serious disease that co-exists with the opiate dependence or

3. reduce the risks of opiate dependence during pregnancy and after delivery.

(2) According to the prerequisites set out in section 13 subsection 1 of the Narcotics Act, a physician may prescribe a substitute drug for a patient if and as long as

1. there are no contraindications to the substitution which are generally acknowledged by medical science,

2. the treatment includes the necessary psychiatric, psychotherapeutical or psychosocial measures of treatment and care,

3. the physician has fulfilled his/her obligations of notification pursuant to section 5a subsection 2,

4. the physician's examinations and inquiries do not suggest that the patient

a) is receiving substitute drugs on prescription from another physician, b) permanently fails to take up the measures of treatment and care required pursuant to number 2, c) is using substances the types and quantities of which jeopardize the purpose of substitution or d) is using the substitute drug prescribed for him/her for purposes other than those intended,

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5. the patient consults the attending physician to the necessary extent, usually every week and

6. the physician meets the minimum qualification requirements for addiction therapy, which are stipulated by the medical associations according to the generally acknowledged state of medical science.

The generally acknowledged state of medical science is decisive for meeting the admissibility requirements pursuant to numbers 1, 2 and 4 letter c.

(3) A physician who does not meet the requirements pursuant to subsection 2 sentence 1 number 6 may prescribe a substitute drug for not more than three patients at a time, if

1. the prerequisites pursuant to subsection 2 sentence 1 numbers 1 to 5 are fulfilled for the duration of the treatment,

2. at the beginning of treatment, he/she agrees on it with a physician who meets the minimum requirements pursuant to subsection 2, sentence 1 number 6 (consultant) and

3. the physician has ensured that his/her patient is presented to the consultant at the beginning of treatment and at least once every quarter.

If a physician who himself/herself does not fulfil the requirements of subsection 2 sentence 1 number 6, works as a locum tenens for the physician pursuant to sentence 1, then sentence 1 numbers 1 and 2 shall apply mutatis mutandis to this locum tenens. A substituting physician pursuant to subsection 2 shall, as a rule, be replaced by another physician who fulfils the requirements pursuant to subsection 2 sentence 1 number 6. If the substituting physician is un- able to appoint a locum tenens as stipulated in sentence 3, he/she can be replaced by a physician who does not fulfil the requirements pursuant to subsection 2 sentence 1 number 6 for a period of up to four weeks and a total of not more than 12 weeks a year. The locum tenens pursuant to sentence 4 shall agree on the substitution treatment with the physician he/she is replacing before starting to work in his/her place. If any unforeseen changes in substitution therapy become necessary during this time, the locum tenens pursuant to sentence 4 shall agree on these again with the physician whom he/she is replacing. If agreement is not possible in time, the locum tenens pursuant to sentence 4 shall consult with another physician who fulfils the requirements set out in subsection 2 sentence 1 number 6. In all cases of a physician replacing another, emergency decisions shall remain unaffected. The correspondence covering the above-mentioned co-operation between the attending physician and the consultant and be-

- 8 - tween the physician being replaced and his/her locum tenens as set out in sentences 2 and 4 shall be enclosed with the documentation pursuant to subsection 10. Sentences 1 to 9 do not apply to treatment pursuant to subsections 9a to 9d.

(4) The prescription of a substitute drug shall be marked with the letter "S". The physician may only prescribe as substitute drugs

1. preparations of levomethadone, methadone and buprenorphine 2. in well-founded exceptional cases, codeine or dihydrocodeine, 3. diamorphine as a medicinal product which has been authorized for substitution or 4. another medicinal product authorized for substitution.

The substitute drugs referred to in sentence 2 numbers 1, 2 and 4 may not be intended for parenteral application. In addition to the provisions of this Ordinance, the generally acknowledged state of medical science shall be decisive in choosing the substitute drug. Subsections 6 to 8 do not apply to the prescription of diamorphine pursuant to sentence 2 number 3.

(5) The physician prescribing the substitute drug for a patient may not hand out the prescription to the patient himself/herself, except in the cases specified in subsection 8. The prescription may only be presented at the pharmacy by himself/herself, his/her locum tenens or the personnel specified in subsection 6 sentence 1. The physician prescribing diamorphine may only present the prescription to a pharmaceutical entrepreneur.

(6) The substitute drug shall be supplied to the patient for immediate consumption by the attending physician, his/her locum tenens or the medical or pharmaceutical personnel or appropriately trained staff in officially recognized addict support institutions, who are instructed or directed and supervised by the physician. The attending physician shall ensure that the personnel specified in sentence 1 is properly instructed on supplying a substitute drug for immediate consumption. In cases where codeine or dihydrocodeine has been prescribed and after the patient has been supplied with one single dose for immediate consumption, the additional quantity needed for one day may be handed out to him/her in separate unit doses and he/she may be allowed to use it on his/her own responsibility, unless the physician has any reason to suspect that the patient will not use the substitute drug as intended.

(7) The substitute drug shall be supplied to the patient for immediate consumption in a physician’s surgery, in a hospital or in a pharmacy or in another suitable facility approved for this purpose by the competent Land authority or, in case of a patient who is medically certified as requiring long-term care, on the occasion of a home visit. The physician may store the required

- 9 - substitute drugs in one of the facilities in his/her charge as specified in sentence 1; the consent by the person entitled to determine the use of the premises concerned shall not be affected. Sections 13 and 14 shall apply mutatis mutandis to the proof of disposition and stocks.

(8) Deviating from subsections 5 to 7, the physician or his/her locum tenens working in his/her surgery may prescribe for the patient who is being supplied with a substitute drug pursuant to subsection 6 for immediate consumption, in cases where the continuity of substitution treatment cannot be otherwise ensured, the substitute drug at quantities that keep the patient supplied for up to two days and allow him/her to use it on his/her own responsibility as soon as and as long as the progress of the treatment allows this, risks of the patient harming himself/herself or others are excluded as far as possible and this practice does not impair the security and control of the trade in narcotic drugs. The physician may not hand out to the patient, within the period of one week, more than one prescription pursuant to sentence 1. Without prejudice to subsection 4 sentence 1, the physician shall additionally label this prescription with the letter "Z".

As soon as and for as long as the patient's condition has stabilised and it is no longer necessary to supply the substitute drug for immediate consumption, the physician may hand out to the patient an up to seven days' supply of the substitute drug and allow him/her to use it at his/her own responsibility. Handing out a prescription pursuant to sentence 4 shall not be admissible, in particular, in those cases where the physician's examinations and inquiries have revealed that the patient

1. consumes substances which place him/her at risk when used in conjunction with the substitute drug,

2. has not yet had a stable dose determined considering tolerance development or

3. misuses any substances.

Over and above that, the generally acknowledged state of medical science shall be decisive for evaluation of the treatment progress by the substituting physician. If a patient who is already prescribed substitute drugs pursuant to sentence 4 plans to go abroad, the physician may, considering all the requirements for ensuring the patient's supply, hand out to the patient prescriptions amounting to a quantity of the substitute drug that keeps him/her supplied for a period of time longer than that mentioned in sentence 4 and may allow him/her to use it on his/her own responsibility. In one year, the total of these prescriptions may not exceed the quantity of the substitute drug needed for up to 30 days. They shall be notified immediately to

- 10 - the competent Land authority. Any prescription pursuant to sentences 1, 4 or 8 shall be handed out to the patient in the context of a personal medical consultation.

(9) Patients who change their attending physician's surgery temporarily or permanently shall have a substitution certificate issued by their attending physician on a narcotic drug prescription form prior to the continuation of their substitution treatment. The substitution certificate shall include the following particulars:

1. the family name, given name and address of the patient for whom the narcotic drug is intended, 2. the date of issue, 3. the prescribed substitute drug and the daily dosage, 4. the start of the prescription and supply pursuant to subsections 1 to 7 and, where necessary, the start of the prescription pursuant to subsection 8, 5. validity: from/to, 6. the name of the issuing physician, his/her professional title and address including his/her telephone number, 7. the signature of the issuing physician.

The substitution certificate shall bear the note "Nur zur Vorlage beim Arzt" (Only for presentation to a physician). Part I of the substitution certificate shall be given to the patient, parts II and III shall be retained by the issuing physician. After the patient has presented part I of the substitution certificate and the personal data have been checked against the patient's identity card or passport, another physician may continue prescribing the substitute drug; if the other physician does so only temporarily, he/she shall inform the attending physician of the measures carried out in writing immediately after the end of his/her prescribing.

(9a) The substitute drug diamorphine may be prescribed for parenteral application to man- age a severe opiate dependence. The physician may only prescribe diamorphine if 1. he himself/she herself has acquired an addiction therapy qualification as specified in subsection 2 sentence 1 number 6 that covers the treatment with diamorphine or he/she has worked as a physician within the framework of the pilot project "Heroingestützte Behandlung Opiatabhängiger" ("heroin-based treatment of opiate addicts") for at least six months,

2. the patient has an at least five years history of opiate dependence, associated with severe somatic and psychological disorders and a current predominantly intravenous use

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pattern,

3. evidence can be furnished of two failed opiate dependence therapies, at least one of which of not less than six months duration pursuant to subsections 2, 6 and 7, including psychosocial care and

4. the patient has completed his/her 23rd year of life.

(9b) The treatment with diamorphine may only be carried out in facilities that have been granted an authorisation by the competent Land authority. This authorisation is granted if

1. evidence can be furnished that the facility is embedded in the local addict support sys- tem,

2. it is ensured that the facility is appropriately staffed and equipped,

3. a competent person has been appointed who is responsible for compliance with the requirements set out in number 2, the requirements stipulated by the authorising authority as well as the orders from the monitoring authority (responsible person).

(9c) Diamorphine may only be prescribed, administered and supplied for immediate consumption within the facility specified in subsection 9b. Diamorphine may only be consumed under the supervision of the physician or the competent staff inside this facility. During the first six months of treatment, measures of psychosocial care shall be provided.

(9d) Any treatment with diamorphine shall be reviewed at intervals not longer than every two years of treatment to check if the prerequisites for treatment still exist and if treatment is to be continued. This review shall be made by obtaining a second opinion from a physician who has the qualification set out in subsection 2 sentence 1 number 6 and who is not a member of the facility. If this examination reveals that the prerequisites for treatment have ceased to exist, diamorphine-based treatment shall be terminated.

(10) The physician shall document the discharge of his/her obligations pursuant to the above subsections as well as section 5a subsections 2 and 4 to the necessary extent and according to the generally acknowledged state of medical science. Upon request, the documentation shall be submitted or sent to the competent Land authority for inspection and evaluation.

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(11) The German Medical Association may stipulate the generally acknowledged state of medical science in guidelines covering

1. compliance with the admissibility prerequisites pursuant to subsection 2 sentence 1 numbers 1, 2 and 4 letter c, 2. the choice of the substitute drug pursuant to subsection 4 sentence 4 and 3. the evaluation of the treatment outcome achieved so far pursuant to subsection 8 sentences 1 and 4 and issue guidelines for documentation pursuant to subsection 10. Compliance with the generally acknowledged state of medical science shall be assumed if and as long as the guidelines of the German Medical Association pursuant to items 1 to 3 have been observed.

(12) Subsections 2 to 10 shall be applied accordingly if the substitute drug is supplied for immediate consumption from the stocks required for the surgery or the hospital ward or handed out pursuant to subsection 6 sentence 3.

Section 5a Substitution register

(1) The Federal Institute for Drugs and Medical Devices (Federal Institute) shall keep a register with data on the prescription of substitute drugs (substitution register) on behalf of the Laender in its capacity as an entity on loan from the Federal Government. The data on the substitution register may only be used for the purpose of

1. preventing as early as possible the prescription of a substitute drug by several physicians for the same patient and the same period of time,

2. checking compliance with the minimum requirements set out in section 5 subsection 2 sentence 1 number 6 and the requirements set out in section 5 subsection 3 sentence 1 numbers 2 and 3 as well as

3. statistically evaluating the prescription of substitute drugs according to the provisions of section 13 subsection 3 number 3 letter e of the Narcotics Act.

The Federal Institute shall issue organizational stipulations on the maintenance of a substitution register.

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(2) Any physician prescribing a substitute drug for a patient shall immediately report the following data to the Federal Institute, in writing or encrypted by e-mail:

1. the patient code, 2. the date of the first prescription, 3. the substitute drug prescribed, 4. the date of the latest prescription, 5. the name and address of the prescribing physician as well as 6. in case of a prescription pursuant to section 5 subsection 3, the name and address of the consultant.

The patient code is composed as follows: a) first and second positions: first and second letters of the first given name, b) third and fourth positions: first and second letters of the family name, c) fifth position: sex ("F" for female, "M" for male), d) sixth to eighth positions: the last figure each of the date, month and year of birth.

It is not admissible to report uncoded patient data to the Federal Institute. The physician shall check the personal data against the patient's identity card or passport.

(3) The Federal Institute shall immediately encrypt the patient code pursuant to subsection 2 sentence 1 number 1 in accordance with a procedure specified by the Federal Agency for Safety in Information Technology so that it cannot, or only with unreasonable efforts, be de- crypted. The cryptogram shall be stored together with the data pursuant to subsection 2 sentence 1 numbers 2 to 6 and shall be deleted not later than six months after notice has been given of the end of prescriptions. The data stored and the encrypting procedure pursuant to sentence 1 shall be protected against unauthorized access and use by appropriate security measures.

(4) The Federal Institute shall compare any newly stored cryptogram with the already exist- ing ones. If there is no match, the patient code shall be deleted immediately. If there is any match, the Federal Institute shall immediately inform every physician involved accordingly, stating the patient code, the date of the first prescription and the addresses of the other physicians involved. The physicians shall state whether this patient code refers to the same patient. If it does, they shall agree on who will prescribe substitute drugs for the patient in the future and inform the Federal Institute on the result of their agreement, stating the patient code. If it does not, the physicians shall also inform the Federal Institute, stating the patient code. The substitution register shall be corrected without delay. If necessary, the Federal Institute shall inform the

- 14 - monitoring authorities responsible for the physicians involved to prevent the prescribing of substitute drugs by several physicians for one single patient.

(5) By 31st March and 30th September the Medical Associations shall notify the Federal In- stitute of the names and addresses of the physicians meeting the minimum requirements pursuant to section 5 subsection 2 sentence 1 number 6. The Federal Institute shall immediately inform the competent monitoring authorities at Laender level of the names and addresses of

1. physicians who have prescribed a substitute drug pursuant to section 5 subsection 2 and 2. consultants notified in accordance with subsection 2 number 6, if these do not meet the minimum requirements pursuant to section 5 subsection 2 sentence 1 number 6.

(6) The Federal Institute shall notify the competent monitoring authorities by 30th June and 31st December of the following:

1. the names and addresses of the physicians who have prescribed substitute drugs pursuant to section 5 subsection 2,

2. the names and addresses of the physicians who have prescribed substitute drugs pursuant to section 5 subsection 3,

3. the names and addresses of the physicians who meet the minimum requirements pursuant to section 5 subsection 2 sentence 1 number 6, 4. the names and addresses of the physicians who have been notified as consultants pursuant to subsection 2 number 6 as well as

5. the number of patients for whom a substitute drug has been prescribed by a physician mentioned under number 1 or 2.

In individual cases, the competent monitoring authorities shall be empowered to request information to that effect from the Federal Institute at any time.

(7) By 31st December the Federal Institute shall notify the supreme health authority of each Land of the following in respect of this Land:

1. the number of patients for whom a substitute drug has been prescribed,

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2. the number of physicians who have prescribed substitute drugs pursuant to section 5 subsection 2,

3. the number of physicians who have prescribed substitute drugs pursuant to section 5 subsection 3,

4. the number of physicians who meet the minimum requirements pursuant to section 5 subsection 2 sentence 1 number 6,

5. the number of physicians who have been notified as consultants pursuant to subsection 2 number 6 as well as

6. the type and amount of the prescribed substitute drugs.

Upon request, the supreme health authorities of the Laender shall receive the information listed in numbers 1 to 6 also broken down into monitoring areas.

Section 5b Prescribing for residents of old-age and nursing homes as well as hospices

(1) The physician prescribing a narcotic drug for a resident of an old-age and nursing home or of a hospice may determine that the prescription not be handed out to the patient. In such a case, the prescription may only be presented at the pharmacy by himself/herself or by personnel of his/her surgery, the old-age and nursing home or the hospice who are instructed or directed by him/her.

(2) In the case described in subsection 1 sentence 1, the narcotic drug shall be supplied to the patient for immediate consumption by the attending physician or the personnel of the old- age and nursing home or the hospice who are directed, instructed and supervised by him/her.

(3) In the case described in subsection 1 sentence 1, the physician may store the patient's narcotic drugs at the old-age and nursing home or the hospice in his/her charge; this shall not affect the consent of the person entitled to determine the use of the premises concerned. Sec- tions 13 and 14 shall apply, mutatis mutandis, to the proof of disposition and stocks.

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(4) Narcotic drugs stored in line with subsection 3 that are no longer needed, can be prescribed again for another patient of this old-age and nursing home or hospice or returned to a supplying pharmacy for further use in an old-age and nursing home or hospice.

Section 6 Prescribing for emergency service facilities

(1) The provisions on prescribing for the supply of hospital wards pursuant to section 2 subsection 4 shall apply, mutatis mutandis, to the prescribing of narcotic drugs needed for emergency service facilities and their units.

(2) The entity responsible for or the entity carrying out the emergency service shall com- mission a physician to prescribe the narcotic drugs needed pursuant to section 2 subsection 4. The records on the disposition and stock of narcotic drugs at the emergency service facilities and their units shall be kept according to sections 13 and 14 by the physician treating the cases.

(3) The entity responsible for or the entity carrying out the emergency service shall con- clude a written agreement with a pharmacy, specifying the latter’s supply of the substances set forth in the ward prescriptions and inspection of the stocks of narcotic drugs kept at the emergency service facilities or their units - at least every six months - with regard to their faultless condition as well as proper and secure storage. The undersigning pharmacist shall notify the competent Land authority thereof. A pharmacist from the pharmacy involved shall be charged with inspecting the stocks of narcotic drugs. A record shall be drawn up. For the purpose of cor- recting any detected deficiencies, the pharmacist charged with the inspection shall set the entity responsible for or the entity carrying out the emergency service an appropriate time limit and inform the competent Land authority if this time limit is exceeded.

(4) In a case of heavy casualties, the required narcotic drugs shall be prescribed by the competent emergency physician in charge pursuant to section 2 subsection 4. The narcotic drugs used for heavy casualties shall be summarily recorded immediately by the emergency physician in charge and reported to the competent Land authority, stating any unused narcotic drugs. The competent Land authority shall issue stipulations on the disposition of any unused narcotic drugs.

Section 7 Prescribing for merchant ships

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(1) Sections 8 and 9 shall apply to the prescribing and dispensing of narcotic drugs for the outfitting of merchant ships. On the narcotic drug prescription forms, the particulars mentioned in subsection 4 numbers 4 to 6 below shall be entered instead of those stipulated under section 9 subsection 1 numbers 1 and 5.

(2) Only a physician commissioned by the competent authority may prescribe narcotic drugs for the outfitting of merchant ships; if the crew does not include a ship's doctor, the physician may prescribe only the narcotic drug morphine for this purpose. For the outfitting of a merchant ship whose crew includes a ship's doctor and those not flying the Federal flag it shall also be permitted to prescribe any of the other narcotic drugs specified in Annex III to the Nar- cotics Act.

(3) As an exception, narcotic drugs may be dispensed by a pharmacy, initially without a prescription, for the outfitting of merchant ships that fly the Federal flag if:

1. the physician specified in subsection 2 cannot be contacted in time before the ship leaves harbour,

2. the drugs are dispensed in terms of type and quantity only to replace narcotic drugs that

a) have been used up, b) have become unusable or c) were obtained outside the area of application of the Narcotics Act by ships that fly the Federal flag and have to be replaced according to the Ordinance on Medical Care on Merchant Ships (Verordnung über die Krankenfürsorge auf Kauffahrteis- chiffen),

3. the dispenser has previously satisfied himself/herself that the stocks of narcotic drugs on hand comply with the entries in the ship's narcotic drugs register in terms of type and quantity and

4. the dispenser obtains certification of receipt from the person responsible for the proper delivery of medical care.

(4) The certification pursuant to subsection 3 number 4 must contain the following particulars:

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1. the names of the medicinal products prescribed pursuant to section 9 subsection 1 number 3, 2. the quantity of the medicinal products dispensed pursuant to section 9 subsection 1 number 4, 3. the date of dispensing, 4. the name of the ship, 5. the name of the ship-owner, 6. the ship's home port and 7. the signature of the person responsible for medical care.

(5) The dispenser must present the certification pursuant to subsection 3 number 4 without delay to the physician commissioned by the competent Land agency for subsequent prescription. The physician is obliged to immediately hand in the prescription on a narcotic drug prescription form to the pharmacy that had supplied the narcotic drug pursuant to section 7 subsection 3. The prescription shall be marked with the letter "K". The certification pursuant to section 7 subsection 3 number 4 shall be permanently attached to the part of the prescription re- maining at the pharmacy. If the prerequisites of subsection 3 numbers 1 and 2 have not ex- isted, the competent authority shall be informed without delay.

(6) Subsections 1 to 5 shall apply, mutatis mutandis, to the prescribing and dispensing of narcotic drugs for the outfitting of ships other than merchant ships.

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Section 8 Narcotic drugs prescription forms

(1) Narcotic drugs for patients, for the supply of the surgery and for animals may be prescribed only on a three-part official form (narcotic drug prescription form). This form may only be used for the prescription of other medicinal products if the latter are prescribed in addition to a narcotic drug. Parts I and II of the prescription form are intended for presentation at a pharmacy, in the case of diamorphine prescription pursuant to section 5 subsection 9a for presentation to a pharmaceutical entrepreneur, part III shall be retained by the physician, dentist or veterinarian to whom the narcotic drug prescription form was issued.

(2) Narcotic drug prescription forms are issued upon request by the Federal Institute for Drugs and Medical Devices to individual physicians, dentists or veterinarians. The Federal In- stitute for Drugs and Medical Devices can refuse issue if there is a reasonable suspicion that the narcotic drug prescription forms will not be used in accordance with the provisions of the narcotic drugs legislation.

(3) The numbered narcotic drug prescription forms, bearing the date of issue by the Federal Institute for Drugs and Medical Devices and the narcotic drug prescriber's number of the individual physician, dentist or veterinarian are intended for use only by the latter and may be transferred only to a locum tenens. Unused narcotic drug prescription forms shall be returned to the Federal Institute for Drugs and Medical Devices when the physician, dentist or veterinarian ceases to practise.

(4) The physician, dentist or veterinarian shall secure the narcotic drug prescription forms against theft. Any loss must be reported immediately, stating the serial numbers of the prescription forms, to the Federal Institute for Drugs and Medical Devices which shall inform the competent supreme authority of the Land.

(5) The physician, dentist or veterinarian shall keep part III of the completed prescription forms and parts I to III of the incorrectly completed narcotic drug prescription forms filed by date of issue or according to the requirements of the competent Land authority for three years and send them upon request to the competent Land authority according to section 19 subsection 1 sentence 3 of the Narcotics Act or present them to the officials of that authority.

(6) Except in the cases specified in section 5, narcotic drugs may be prescribed in cases of emergency for patients, for the supply of the surgery, and for animals, deviating from subsection 1 sentence 1, in restricted quantities as required for the management of the emergency.

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Prescriptions according to sentence 1 shall include the particulars specified in section 9 subsection 1 and shall be marked with the word "Notfall-Verschreibung" (emergency prescription). Immediately upon presentation of the emergency prescription and, if possible, prior to the dispensing of the narcotic drug, the pharmacy shall inform the prescribing physician, dentist or veterinarian about the supply. He/she shall be obliged to immediately hand in the prescription on a narcotic drug prescription form to the pharmacy that had dispensed the narcotic drugs on the emergency prescription. The prescription has to be marked with the letter "N". The emergency prescription shall be permanently attached to the part of the subsequently submitted prescription that remains at the pharmacy.

Section 9 Particulars to be stated on narcotic drug prescription forms

(1) The following particulars must be stated on narcotic drug prescription forms:

1. the name, given name and address of the patient for whom the narcotic drug is intended; in the case of veterinary prescriptions, the animal species and the family name, given name and address of the animal owner,

2. the date of issue,

3. the name of the medicinal product, as far as it does not clearly determine one of the following particulars, and, in addition, the name and weight of the narcotic drug content per package unit and, in the case of apportioned preparations, the above particulars per dosage unit, dosage form,

4. the quantity of the prescribed medicinal product in grammes or millilitres, the number of dosage units,

5. the instructions for use with the individual or daily dose or in the event that the patient was given written instructions for use, the note "Gemäß schriftlicher Anweisung" (according to written instructions); in the cases covered by section 5 subsection 8 also the period of time for which the substitute drug will last, expressed in days,

6. in the cases covered by section 2 subsection 2 sentence 2 and section 4 subsection 2 sentence 2 the letter "A", in the cases covered by section 5 subsection 4 sentence 1 the letter "S", in the cases covered by section 5 subsection 8 sentence 1 additionally the let-

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ter "Z", in the cases covered by section 7 subsection 5 sentence 3 the letter "K", in the cases covered by section 8 subsection 6 sentence 5 the letter "N",

7. the name of the prescribing physician, dentist or veterinarian, his/her professional title and address including telephone number,

8. in the cases covered by section 2 subsection 3, section 3 subsection 2 and section 4 subsection 3 the note "Praxisbedarf" (Surgery supply) instead of the particulars in numbers 1 and 5,

9. the signature of the prescribing physician, dentist or veterinarian, or if replaced by a locum tenens, the additional note "i.V." (as locum tenens).

(2) The particulars according to subsection 1 shall be entered indelibly and shall appear consistently on all parts of the prescription form. The particulars pursuant to numbers 1 to 8 may be entered by a person other than the prescriber. In the case of an alteration of the prescription, the prescribing physician shall make the alteration in writing on all parts of the narcotic drug prescription form and confirm it by his/her signature.

Section 10 Narcotic drug requisition form

(1) Narcotic drugs required for a hospital ward pursuant to section 2 subsection 4, section 3 subsection 3 and section 4 subsection 4 may be prescribed only on a three-part official form (narcotic drug requisition form). Parts I and II of the ward prescription are intended for presentation at a pharmacy, part III shall be retained by the physician, dentist or veterinarian entitled to prescribe the drugs.

(2) Narcotic drug requisition forms shall be issued by the Federal Institute for Drugs and Medical Devices upon request to the physician or dentist in charge of a hospital or hospital ward, to the veterinarian in charge of an animal hospital, or to the physician commissioned by the emergency service pursuant to section 6 subsection 2 or the competent emergency physician in charge pursuant to section 6 subsection 4.

(3) The numbered narcotic drug requisition forms are intended for use only in the institution headed by the requisitioning physician, dentist or veterinarian. They may be passed on to the persons in charge of other units by the requisitioning physician, dentist or veterinarian. Proof shall be furnished of the passing on of any requisition forms.

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(4) Part III of the ward prescription and parts I to III of the incorrectly completed narcotic drug requisition forms as well as the documents furnishing proof pursuant to subsection 3 shall be kept on file for three years, from the day of the last entry, by the requisitioning physician, dentist or veterinarian and, upon request, shall be sent to the competent authority of the Land specified in section 19 subsection 1 sentence 3 of the Narcotics Act, or presented to the officials of these authorities.

Section 11 Particulars on the narcotic drug requisition form

(1) The following particulars shall be stated on the narcotic drug requisition form:

1. the name or designation and address of the facility for which this ward supply is intended,

2. the date of issue,

3. the names of the prescribed medicinal products pursuant to section 9 subsection 1 number 3,

4. the quantity of the prescribed medicinal products pursuant to section 9 subsection 1 number 4,

5. the name of the prescribing physician, dentist or veterinarian as well as his/her telephone number,

6. the signature of the prescribing physician, dentist or veterinarian, or, if replaced by a locum tenens, the additional note "i.V." (as locum tenens).

(2) The particulars pursuant to subsection 1 must be entered indelibly and must appear consistently on all parts of the ward prescription. Particulars according to numbers 1 to 5 may be entered by a person other than the prescriber. In the case of an alteration of the ward prescription, the prescribing physician shall make the alteration in writing on all parts of the narcotic drugs prescription form and confirm it by his/her signature.

Section 12 Supply and dispensing

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(1) Subject to subsection 2, narcotic drugs may not be dispensed

1. against a prescription

a) which the dispenser can tell should not have been issued under sections 1 to 4, or section 7 subsection 2, b) issued disregarding a provision of section 7 subsection 1 sentence 2, section 8 subsection 1 sentences 1 and 2, or section 9, c) issued more than seven days previously, except in the case of import of a medicinal product pursuant to section 73 subsection 3 of the German Medicinal Products Act or d) that is marked with the letter "K" or "N".

2. against a ward prescription

a) which the dispenser can tell should not have been issued under sections 1 to 4, section 7 subsection 1, or section 10 subsection 3, or b) issued disregarding a provision of section 10 subsection 1, or of section 11,

3. against a prescription pursuant to section 8 subsection 6 that

a) has not been marked pursuant to sentence 2, or b) was issued more than one day previously;

4. against a prescription pursuant to section 5 subsection 8, unless packed in unit dose con- tainers and in a childproof package.

(2) In the case of prescriptions and ward prescriptions that contain an error recognizable to the dispenser, that are illegible or do not fully comply with the provisions pursuant to section 9 subsection 1 or section 11 subsection 1, the dispenser shall be entitled to make alterations after consultation with the prescribing physician, dentist or veterinarian. Particulars pursuant to section 9 subsection 1 number 1 or section 11 subsection 1 number 1 can be altered or sup- plemented by the dispenser if the person presenting the prescription or ward prescription fur- nishes proof or gives a credible assurance of such particulars or if they are otherwise recognizable. The prescribed narcotic drugs or partial quantities thereof may be dispensed against prescriptions or ward prescriptions in which an alteration pursuant to sentence 1 is not possible if the person presenting the prescription gives a credible assurance or it is otherwise recognizable that the case is urgent and requires the immediate use of the narcotic drug. In such cases,

- 24 - the manager of the pharmacy shall immediately inform the prescriber that the drug has been dispensed, and the necessary corrections on the prescription or ward prescription shall be ef- fected without delay. Any alterations and supplementations pursuant to sentences 1 and 2, consultations pursuant to sentences 1 and 4 as well as cases of dispensing pursuant to sentence 3 shall be entered by the dispenser on parts I and II, by the prescriber - except in the case specified in sentence 2 - on part III of the prescription or the ward prescription. Sentences 2 to 4 shall not apply to the prescription of diamorphine.

(3) The dispenser shall enter the following particulars indelibly on part I of the prescription or the ward prescription:

1. the name and address of the pharmacy, 2. the date of dispensing and 3. the initials of the dispenser.

(4) The manager of the pharmacy shall keep part I of the prescriptions and ward prescriptions filed by date of dispensing, or arranged according to the requirements of the competent Land authority and, upon request, send them to the Federal Institute for Drugs and Medical De- vices or the competent Land authority stipulated in section 19 subsection 1 sentence 3 of the Narcotics Act or present them to the officials of those authorities. Part II shall be intended for accounting purposes. In cases involving the dispensing of diamorphine, sentences 1 and 2 shall apply mutatis mutandis to the person responsible for narcotic drugs with the pharmaceutical entrepreneur.

(5) The veterinarian may issue narcotic drugs from his veterinary house dispensary only for application to an animal being treated by him and only in conformity with the provisions of sections 1 and 4 subsections 1 and 2 that are applicable to prescription.

Section 13 Supplying proof

(1) Proof of the disposition and stocks of narcotic drugs in the facilities specified in section 1 subsection 3 shall be supplied immediately after any change in stocks, using an official form. File cards or consecutively paginated narcotic drug registers may be used. The records may also be kept by electronic data processing provided that printouts of the stored data in the se- quence of the official form are guaranteed at any time. In cases where a substitute drug is supplied for immediate consumption pursuant to section 5 subsection 6 sentence 1 or a narcotic

- 25 - drug is supplied pursuant to section 5b subsection 2, proof of the disposition shall be supplied on a patient-by-patient basis.

(2) The following shall review the entries concerning narcotic drugs received, dispensed and in stock and check the consistency of stocks on hand with the records kept at the end of each calendar month and, if the stock has changed, confirm these entries by their initials and the verification date:

1. the pharmacist, for the pharmacy managed by him/her,

2. the veterinarian for the veterinary house dispensary managed by him/her and

3. the physician, dentist or veterinarian specified in sections 2 to 4 who is authorized to prescribe supplies for the surgery or ward,

4. the physician commissioned pursuant to section 6 subsection 2 for the emergency service facilities,

5. the person responsible for medical care on a merchant ship flying the Federal flag,

6. the attending physician, in the cases where proof must be supplied as specified in subsection 1 sentence 4,

7. the responsible person as specified in section 5 subsection 9b number 3.

If proof is supplied via electronic data processing, verification shall be carried out on the basis of computer printouts made at the end of the month.

(3) The file cards, narcotic drug registers or computer printouts pursuant to subsection 2 sentence 2 shall be kept on file in the facilities specified in section 1 subsection 3 for three years as from the day of the last entry. In the case of a change in management of a hospital pharmacy, a hospital facility, an animal hospital or an emergency service, the persons specified in subsection 2 shall record the date on which the duties were handed over as well as the stocks handed over and shall confirm such record by their signature. Upon request, the file cards, narcotic drug registers and computer printouts shall be sent to the competent Land authority pursuant to section 19 subsection 1 sentence 3 of the Narcotics Act or presented to the officials of that authority. In the meantime, provisional records shall be kept and the particulars

- 26 - recorded therein entered on the file cards and narcotic drug registers after the return of the latter.

Section 14 Particulars required for supplying proof

(1) For the purpose of supplying proof of the disposition and stocks of narcotic drugs, the following particulars shall be indelibly stated for each narcotic drug:

1. the name, in the case of medicinal products according to section 9 subsection 1 number 3,

2. the date of receipt or dispensing,

3. the quantity received or dispensed and the resulting stock; in the case of substances and non-apportioned preparations, the weight in grammes or milligrammes, and, in the case of apportioned preparations, the number of units; in the case of liquid preparations that are used within the scope of a treatment, the quantity also in millilitres,

4. the name or company name and address of the supplier or recipient or alternative prove- nance or alternative disposition,

5. in pharmacies, in the case of dispensing against prescription, in hospitals and animal hospitals in the case of purchase against prescription, the name and address of the prescribing physician, dentist or veterinarian, and the serial number of the narcotic drug prescription form or narcotic drug requisition form,

6. at the pharmaceutical enterprise, in cases where diamorphine is dispensed against prescription the name and address of the prescribing physician and the serial number of the narcotic drug prescription form.

If there are various units in the facilities specified in section 1 subsection 3, the records shall be kept on file in these units. (2) When supplying proof related to liquid preparations, the weight of the narcotic drug that remains in the dispensing container which had to be overfilled for technical reasons shall only be taken into consideration if, as a result, the quantity dispensed exceeds the quantity received. In the records, the difference shall be specified as "Überfüllung" (overfill).

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Section 15 Forms

The Federal Institute for Drugs and Medical Devices shall issue the official forms for prescription (narcotic drug prescription forms and narcotic drugs requisition forms) and for re- cording their disposition and stock (file cards and narcotic drug registers) and shall publish information thereon in the Bundesanzeiger (Federal Gazette).

Section 16 Criminal offences

Pursuant to section 29 subsection 1 sentence 1 number 14 of the Narcotics Act, any person shall be punished who

1. contrary to the provisions of section 1 subsection 1 sentence 1, also in conjunction with sentence 2, does not prescribe a narcotic drug as a preparation,

2. a) contrary to the provisions of section 2 subsection 1 or 2 sentence 1, section 3 subsection 1, or section 5 subsection 1 or subsection 4 sentence 2, prescribes for a patient, b) contrary to the provisions of section 2 subsection 3 sentence 1, section 3 subsection 2 sentence 1 or section 4 subsection 3 sentence 1, prescribes for the supply of his surgery or c) contrary to the provisions of section 4 subsection 1, prescribes for an animal

narcotic drugs other than those specified there or, within a period of 30 days, prescribes more than one narcotic drug, in the case of section 2 subsection 1 letter a, prescribes more than two narcotic drugs, prescribes in excess of the determined maximum quantity or in violation of the intended use or other restrictions,

3. contrary to the provisions of section 2 subsection 4, section 3 subsection 3 or section 4 subsection 4, prescribes a) narcotic drugs for facilities other than those specified there, b) narcotic drugs other than those specified there or c) narcotic drugs specified there in violation of the restrictions mentioned there or

4. contrary to section 7 subsection 2, prescribes narcotic drugs for the outfitting of merchant ships,

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5. contrary to the provisions of section 5 subsection 9c sentence 1 prescribes, administers or supplies diamorphine.

Section 17 Administrative offences

An administrative offence pursuant to section 32 subsection 1 number 6 of the Narcotics Act shall be deemed to be committed by anyone who, whether intentionally or negligently

1. contrary to the provisions of section 5 subsection 9 sentences 2 and 3, also in conjunction with section 5 subsection 12, section 5a subsection 2 sentences 1 to 4, section 7 subsection 1 sentence 2 or subsection 4, section 8 subsection 6 sentence 2, section 9 subsection 1, also in conjunction with section 2 subsection 2 sentence 2, section 4 subsection 2 sentence 2, section 5 subsection 4 sentence 1, section 7 subsection 5 sentence 3 or section 8 subsection 6 sentence 5, section 11 subsection 1 or section 12 subsection 3, does not, not correctly, not completely or not in time state particulars,

2. contrary to the provisions of section 5 subsection 10 does not or not completely document the required measures or does not present or send this documentation to the competent Land authority for inspection and evaluation,

3. contrary to the provisions of section 8 subsection 1 sentence 1, also in conjunction with section 7 subsection 1 does not prescribe narcotic drugs on a valid narcotic drug prescription form or, contrary to the provisions of section 10 subsection 1 sentence 1, also in conjunction with section 6 subsection 1, does not prescribe narcotic drugs on a valid narcotic drug requisition form,

4. contrary to the provisions of section 8 subsection 3, transfers certain narcotic drug prescription forms intended for his/her use or does not return them to the Federal Institute for Drugs and Medical Devices when he/she ceases to practise, 5. contrary to the provisions of section 8 subsection 4, does not secure narcotic drug prescription forms against theft or does not immediately report their loss,

6. contrary to the provisions of section 8 subsection 5, section 10 subsection 4 or section 12 subsection 4 sentence 1, does not keep the parts of the prescription or ward prescription specified there on file or does not keep them on file as stipulated,

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7. contrary to the provisions of section 8 subsection 6 sentence 4, does not immediately hand in the prescription to the pharmacy,

8. contrary to the provisions of section 10 subsection 3 sentence 3, does not furnish proof of the passing on of the narcotic drug requisition forms,

9. infringes a provision of section 13 subsection 1 sentence 1, subsection 2 or 3 or section 14 on the keeping of records, their verification or storage or

10. contrary to the provisions of section 5 subsection 2 sentence 1 number 6 or subsection 3 sentence 1 numbers 2 and 3, sentences 2 and 7 or sentences 5 and 6 or subsection 9a sentence 2 number 1, prescribes a substitute drug without meeting the minimum requirements for qualification or without involving a consultant in the treatment or, being a locum tenens who does not meet the minimum requirements for qualification, without consultation on the treatment, or without meeting the diamorphine-specific requirements for qualification stipulated in subsection 9a number 1.

Section 18 Transitory provisions

(1) As of 1st January 2000, section 5 subsection 3 sentence 2 shall apply to the prescription of a substitute drug for narcotic drug-dependent persons who have received codeine or dihydrocodeine as substitute drugs on prescription prior to the entry into force of this Ordinance.

(2) Section 5 subsection 7 number 1 shall also be deemed as complied with if, at the time of entry into force of this Ordinance, codeine or dihydrocodeine has been prescribed for a patient for substitution purposes in the same surgery for at least six months.