Use of unapproved radiopharmaceuticals
Due to the current supply situation of certain radiopharmaceuticals, the Federal Office for Safety in Health Care (BASG)/AGES PharmMed points out particularities in the use of unapproved medicinal specialties, especially with unapproved radiopharmaceuticals.
Radiopharmaceuticals are considered medicinal products/specialties and are therefore subject to the German Medicines Act (AMG) . Labeling kits, generators and radioactive precursors used for the production of radiopharmaceuticals are also classified as drugs.
The Medicinal Products Act and the associated Medicinal Products Ordinance 2009 provide for certain exemption provisions to take account of the specifics of radiopharmaceuticals (e.g. their half-life). In nuclear medicine practice, however, certain requirements must be observed. Thus, when producing and dispensing such preparations, the requirements of the Radiation Protection Act must be taken into account in addition to those of pharmaceutical law.
In the following, the specifics of the aspects of drug law may be discussed.
- Production/ manufacturingGenerally, the production / manufacturing of radiopharmaceuticals can take place either in a company with a corresponding license according to § 63 AMG, in a (institutional) pharmacy suitable for this purpose, or by nuclear medicine institutions or laboratories that manufacture radioactive drugs exclusively for the purpose of direct application to patients. So-called "magisterial preparations" on prescription of the treating physician for a specific patient (colloquially also referred to as "clinic requirement") are by definition bound to manufacture exclusively in pharmacies.
- Placing on the marketGenerally, drug specialties that are dispensed in Austria require amarketingauthorization. Radiopharmaceuticals requiring a marketing authorization, which are neither covered by a marketing authorization nor by a so-called "notice of reduced quantities" according to Section 7 (8) AMG, can only be dispensed within the framework of the exemption provision of Section 8 (1) (2) AMG. This provision states that if a physician, dentist or veterinarian authorized to practice independently in Austria certifies that the medicinal product is urgently needed to prevent a threat to life or serious damage to health and that this success cannot be expected to be achieved with an approved and available medicinal product according to the state of scientific knowledge, the prescribed medicinal product does not require a marketing authorization.
- Dispensing§57 AMG regulates the dispensing of medicinal products; Paragraph 3 states that these may only be dispensed by the manufacturer, distributor or wholesaler to holders of a license for the handling of radioactive substances in accordance with the Radiation Protection Act.
- Use of unapproved drugsTheapproval process for a drug is time-consuming and costly. Especially in research-oriented areas such as oncology, medical knowledge often precedes drug approval. When using medicinal products in the non-approved area, there is an increased obligation to inform patients as well as liability issues for the treating physicians. § Section 49 (1) of the Medical Act states that a physician is obliged [...] to safeguard the well-being of the sick and the protection of the healthy in accordance with medical science and experience and in compliance with existing regulations and professional quality standards. If a physician uses a drug outside of the approved indication or uses an unapproved drug, the physician's liability insurance will also examine whether less risky alternatives would have been available in the event of a claim. This raises the question of whether the physician negligently (and thus culpably) breached his duty of care. This is to be emphasized in particular if approved drugs were available in an indication. Since subsequently no intended use of the respective applied preparation can be derived, the producer / manufacturer may not be held liable. Attention should also be paid to the related medical duty to inform (e.g. § 8 Abs 3 KAKuG ), because the legality of the treatment depends on the effective consent / approval of the patient. Failure to do so may constitute unauthorized treatment as defined in Section 110 of the Criminal Code.
Queries:
Institute Inspections, Medical Devices & Hemovigilance
Mag. Andreas Kraßnigg
Phone: +43 (0) 50 555-36410
E-mail: inspektionen@ages.at
