The active substances with ATC codes L01–L04 used for cancer treatment were examined as part of the supply report on oncological active substances. The medical necessity of these medicines was defined and the stability of the supply chain evaluated. This report makes a basic distinction between active substances already subject to a reporting obligation and substances for which supply difficulties have arisen due to supply bottlenecks at the pharmaceutical manufacturers. The evaluation is based on fundamental questions concerning the duration and extent of the supply disruption as well as other parameters such as medical need, the possibility of substituting products from alternative suppliers, etc. Accordingly, a distinction is made between a pure reporting obligation and a combined reporting and stockpiling obligation. As a result of the analysis, a reporting obligation (3) or a combined reporting and stockpiling obligation (4) is proposed for the cancer treatment medicines with the ATC codes listed in Tables 3 and 4 in the report.
Adequate volume and fluid therapy is part of very many anaesthesiological, intensive and emergency medical treatments. Patients require intravascular volume therapy “e.g. peri-operatively or peri-interventionally when fasting is medically recommended, or when the enteral fluid absorption rate falls below the necessary substitution rate, e.g. in shock, with large fluid turnover in the context of major surgery, or with reduced enteral absorption as a result of prolonged vomiting or severe diarrhoeaˮ.[1]
In the case of volume replacement solutions, a distinction must be made between crystalloid and colloid solutions. Crystalloid solutions disperse in the intravascular space as well as in the interstitium, and are used for fluid and volume replacement, whereby the volume effect and the intravascular retention time are lower than with colloidal solutions. Colloidal solutions, on the other hand, contain oncotically active macromolecules, tend to remain longer and in larger quantities in the intravascular space and are mainly used for volume replacement. However, the use of colloids such as HES and gelatin solutions has been controversial from a medical point of view for a number of years, hence colloids are seldom used these days. Compared with artificial colloids such as HES and gelatin solutions, the medical value of human albumin (natural colloid) is higher. Although it is also used much less frequently than crystalloid solutions, human albumin must is available, especially for volume replacement in cases of rapid, high blood/plasma loss and hypoalbuminemia. Within the group of crystalloid solutions, the administration of balanced whole electrolyte solutions is preferable to the use of 0.9% sodium chloride solution, as negative effects (hyperchloraemic acidosis) can occur when sodium chloride solution is used because it has a higher chloride content than human plasma and lacks bicarbonate precursors.
Based on the results of this analysis, it is recommended that electrolyte solutions (ATC code B05BB01) as well as solutions with albumin (ATC code B05AA01) be subject to mandatory reporting.
[1] ‘S3-Leitlinie Intravasale Volumentherapie beim Erwachsenen’, published by the Deutsche Gesellschaft für Anästhesiologie und Intensivmedizin, page xi. Available online at https://www.awmf.org/uploads/tx_szleitlinien/001-020l_S3_Intravasale-Volumentherapie-Erwachsene_2020-10.pdf (in German).
Dialysis concentrates and solutions are used to purify the blood of patients with renal insufficiency – a diagnosis that means that their own kidneys can no longer perform this task sufficiently or at all. Different dialysis concentrates and solutions are used depending on the patient and the type of treatment. Most of these products are classified as medical devices (Class IIb); however, some, such as peritoneal dialysis solutions, are registered as medicinal products.
Without dialysis, patients with chronic or acute kidney failure will die; for this reason, the medical necessity of almost all dialysis concentrates and solutions has been rated as high. Certain risk factors in particular affect the supply of dialysis concentrates and solutions: there are usually only few options on the market, there is a low level of substitutability between products because some dialysis machines use proprietary connecting parts, and some products are only stocked in small quantities. It should also be mentioned that hospitals’ contracts for procuring or leasing dialysis machines often require the exclusive use of consumables (incl. dialysis concentrates and solutions) provided by the supplier of the dialysis machine.
This report finds that acidic haemodialysis concentrates, dry bicarbonate concentrates (cartridges and bags) and hypertonic solutions for peritoneal dialysis (ATC code B05DB) should be subject to mandatory reporting. It further recommends that the dialysis and substitution solutions required for acute dialysis/CRRT treatments and the solutions for regional anticoagulation in extracorporeal circulation using trisodium citrate, which are used as standard in acute dialysis, should also be subject to mandatory reporting.
Last modification 21.02.2023
