On 30th November 2022, the Advisory Council for Delivery and Supply Shortages according to section 52b subsection 3b of the Medicinal Products Act (AMG) held a meeting to discuss further measures to mitigate the shortages of paediatric medicines containing paracetamol and ibuprofen (suppositories and juices).

During consultations it became clear that no conclusion can be drawn from the available data about a supply shortage, medicines are continuously being brought onto the market. Nevertheless, it is clearly evident that, among other things, the current increased respiratory infection rate in children is leading to an increased demand for these products. This cannot be fully compensated for at present.
Between end of June 2022 and beginning of July 2022, the information became public that one of the largest suppliers of the products in question cancelled the upcoming winter stockpiling. As a result, a significant increase in purchases by pharmacies could be observed, which primarily affected the dosage forms that had been less affected up to that point (fever juice with ibuprofen and suppositories with paracetamol). As a result, the availability of the products again decreased noticeably. At the same time, the sharp increase in purchases led to regional imbalances and stockpiling with the available stocks. Therefore, in addition to the increased demand, a distribution problem was assumed.

The members of the Advisory Council for Delivery and Supply Shortages according to section 52b subsection 3b AMG agreed on the recommendations listed below to mitigate the shortages. The observance and implementation of these recommendations should be urgently considered by pharmacies and medical professionals.
The recommendations include the following points:

• In order to prevent regional undersupply, it is strongly recommended that pharmacies and in full-service pharmaceutical wholesalers refrain from stockpiling beyond the level of a weekly demand . Stockpiling to the usual extent or beyond is not feasible with current stocks or will lead to a shortage elsewhere.
• The dispensing of a fixed oral dosage form should be examined, taking into account the age of the patient and the availability of the dosage form. For this purpose, reference is made to the dosage tables in the relevant expert information of medicinal products containing ibuprofen and paracetamol, in which, in the case of divisible tablets, the intake for children from four years of age (paracetamol) and from 6 years of age (ibuprofen) is stated. The dosage form juice should only be dispensed to children and adolescents from 9 years of age on prescription if the intake of solid dosage forms is not possible.
• Reference is again made to the recommendations of the Advisory Council meeting of 02.08.2022, according to which, in agreement with the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband), The National Association of Statutory Health Insurance Physicians (KBV) and the Federal Union of German Associations of Pharmacists (ABDA), the preparation of prescriptions or preparations of the products in question is advocated. This is supported by the urgent recommendation of the National Association of Statutory Health Insurance Funds to its members to reimburse the higher costs arising from this measure. Furthermore the corresponding prescriptions should also be considered separately in the performance audit of the practices. The recommendations from August can be found further down on this page.

Coordination of the compensation measures between the BfArM, National Association of Statutory Health Insurance Funds, The National Association of Statutory Health Insurance Physicians and Federal Union of German Associations of Pharmacists

In connection with the currently limited availability of juices against fever for children with the active ingredients paracetamol and ibuprofen, the BfArM has carried out extensive research and examinations, the results of which indicate not only the withdrawal of a market participant but also a distribution problem.

As far as the BfArM is aware a supply disruption has not occurred at any time and the quantities of goods supplied to the market in direct sales or via the full-supply wholesalers represent the average demand to date.

In 2022, the demand for the medicinal products concerned increased disproportionately. The reasons for this could not yet be determined.

In agreement between the BfArM, the National Association of Statutory Health Insurance Funds (GKV Spitzenverband), The National Association of Statutory Health Insurance Physicians (KBV) and the Federal Union of German Associations of Pharmacists (ABDA), the production of individual prescription medicinal products in pharmacies on the basis of a doctor's prescription can be used as a compensatory measure.

This measure is to be used exclusively in individual cases if the child's disease condition requires treatment with the active substances in question.

The following conditions have been agreed upon:

• The fever juice was prescribed by the attending doctor.
• The unavailability of the prescribed finished medicinal product must be documented in the pharmacy. The documentation in the inventory management systems is considered sufficient for this purpose.
• If the prescribed drug is not available, consultation on drug alternatives takes place with the attending physician.
• In the event that the administration of paracetamol or ibuprofen-containing antipyretics is medically necessary and several medicinal products are prescribed on one prescription, a new prescription must be issued for one prescription.
  It is therefore recommended to issue a separate prescription each time a paracetamol or ibuprofen-containing fever juice is prescribed during the period of restricted availability.
  In the event of non-availability, the pharmacy can add a note to the prescription for the substitution of a prescription after consultation with the attending physician.
• The prescription is valued according to the Pharmaceutical Price Ordinance.
• It is provided that a longer period of unavailability is proven by the BfArM. This can be equated with a medical prescription for the production of defective products in the pharmacy.
• The National Association of Statutory Health Insurance Funds will inform the health insurance funds and strongly recommend that pharmacies be reimbursed for prescriptions by the health insurance funds during the period of restricted availability.
• The National Association of Statutory Health Insurance Physicians and the National Association of Statutory Health Insurance Funds recommend that the contracting parties to the regional agreements on performance auditing pursuant to section 106b sub-section 1 of the German Social Code Book V, take into account the additional costs incurred by prescribing prescriptions instead of finished medicinal products during the period of a shortage identified by the Advisory Council in the context of performance audits.