Narcotics traffic; monitoring

According to federal law, the highest state authorities, in this case the Bavarian State Ministry of Health and Care (StMGP), are generally responsible for monitoring medical narcotics traffic as so-called drug monitoring authorities, unless this state authority assigns responsibility to another body. The federal states, including Bavaria, make regular use of this option.

This task was assigned to the district administrative authorities by ordinance, so that they are responsible through their health authorities for monitoring medical narcotics traffic in pharmacies, medical and dental practices, hospitals, retirement and nursing homes, hospices, specialized outpatient palliative care facilities, emergency service facilities and facilities where treatment with the substitution drug diamorphine takes place. They are also responsible for the prosecution and punishment of administrative offenses arising from narcotics law. Municipalities that do not perform the tasks of the health authorities involve the locally responsible health authority.

The objects of the review are in particular

• Proof of the whereabouts and stock of narcotics
  In particular, it must be determined whether the prescribed index cards or narcotics registers are used, properly maintained and stored as proof of the whereabouts and stock of narcotics (Section 13 BtMVV). If the records are kept using electronic data processing, the audit must be carried out on the basis of printouts made at the end of the month.
• Narcotics prescriptions and narcotics request forms
  In particular, it must be checked whether the provisions on prescribing narcotics have been observed (Section 13 para. 1 BtMG, Sections 1 to 11 BtMVV). In addition, compliance with the requirements for the orderly storage of prescriptions and request slips and for dispensing slips in accordance with the Narcotics Internal Trade Ordinance (BtMBinHV) must be checked.
• Storage of narcotics
  It must be determined whether the narcotics are stored separately and secured against unauthorized removal (Section 15 sentence 1 BtMG). The "Guidelines on measures for securing stocks of narcotics in hospitals, public pharmacies, doctors' surgeries and retirement and nursing homes" issued by the Federal Institute for Drugs and Medical Devices - Federal Opium Agency - are taken into account here.
• Minutes on the destruction of narcotics
• Stock of narcotics
  Stock checks are generally only carried out on a random basis.
• Monitoring of narcotics traffic in substitution, in particular with regard to the above-mentioned areas.

Reports or reports of suspected violations of narcotics regulations in the above-mentioned medical facilities must therefore be addressed to the local health authority responsible for the facility.

Narcotics (BtM) may only be prescribed on the official forms provided for this purpose, the BtM prescriptions and the BtM request forms, and only by doctors. BtM prescriptions and BtM request forms are issued by the Federal Opium Agency.

The legal basis for the prescription and dispensing on prescription of BtM can be found in Section 13 of the Narcotics Act (BtMG). This states, among other things, that narcotics may only be prescribed if their use on the human or animal body is justified and the intended purpose cannot be achieved in any other way. For therapeutic purposes, only the narcotics listed in Annex III of the Narcotics Act (BtMG) may be prescribed by a doctor, dentist or veterinarian.

What must be observed when prescribing narcotics is regulated in the Narcotics Prescription Ordinance (BtMVV).

• §§ 19 ff. Act on the Traffic in Narcotics (Narcotics Act - BtMG)
• Ordinance on the Responsibilities of the Drug Monitoring Authorities and on the Enforcement of the Semen Donor Register Act and the Genetic Diagnostics Act (Ordinance on the Responsibilities of the Drug Monitoring Authorities - ZustVAMÜB)
• Ordinance on the Prescription, Dispensing and Proof of Destination of Narcotics (Narcotics Prescription Ordinance - BtMVV)
• Enforcement of narcotics regulations and monitoring of narcotics traffic - Announcement by the Bavarian State Ministry of Health and Care dated December 2, 2013