Defect
The defecture according to the German pharmacy regulations § 8 enables the preparation of a drug in advance. Colloquially, defects are also referred to as extended recipes or recipes for stock . In contrast, formulations are drugs that are manufactured in a pharmacy on the basis of an individual prescription or a specific patient's request.
A manufacturing protocol must be drawn up for each manufacturing process. The protocol must contain at least:
- the name and dosage form,
- the type, quantity, quality, batch designation or test number of the raw materials used,
- the manufacturing instructions underlying the manufacture of the medicinal product,
- the date of manufacture or the batch number,
- the expiry date,
- the name of the pharmacist responsible for production.
In addition, the quality of the pharmaceuticals produced must be checked. The procedure, scope, results and date of the test must be recorded in a test report. Since the change in the pharmacy operating regulations in 2012, it is no longer possible to dispense with the testing of the drug . The organoleptic test permitted for recipes is not sufficient in the case of defects, since according to the Federal Ministry of Health, according to current criteria for pharmaceutical production that goes beyond the individual case, under safety aspects, any analytical test to determine the quality of the finished product cannot be dispensed with. According to the Pharmacopoeia , the test should be based on the risk posed by the drug in question. A practicable model for the risk assessment of defective drugs, which is based on the resolution of the Council of Europe, was established by Andreas Ziegler. The risk-based tier system presented there met with a very positive response from the pharmaceutical university professors and representatives of the Chamber of Pharmacists. It complies with the legal requirements for manufacturing and testing defects as well as the national and international pharmaceutical regulatory environment; As far as possible, the recommendations of international guidelines are taken up, taking into account German specifics where necessary. The limit values of the individual risk classes were taken from internationally agreed recommendations or rationally derived from pharmaceutical aspects. In total, the result achieved is in line with the pronouncements of the relevant specialist groups or national monitoring bodies. It therefore corresponds to the recognized pharmaceutical rules and can be used by the responsible pharmacists to assess the risk of the defective drugs manufactured by them or under their supervision. In addition, pharmacy-specific aspects can be taken into account as far as technically justifiable. Specific test recommendations and sample test instructions can be found in the relevant specialist literature.
Although defects are finished medicinal products , they are not subject to authorization according to the German Medicines Act . They may only be made if it can be proven that they are often prescribed; in addition, a maximum of 100 ready-to-sell packs may be made daily within the scope of normal pharmacy operations (hundreds of rule).
In the Austrian Medicines Act there is the term official preparation , in the Swiss Medicines Act the term Formula officinalis ; Both terms refer to drugs that are manufactured in a pharmacy for their own customers according to a monograph in the pharmacopoeia. Essentially, this corresponds to the defect in Germany.
See also
Web links
Individual evidence
- ↑ wcd.coe.int , accessed April 12, 2014.
- ↑ a b A. S. Ziegler: Basics of Defect Inspection - Risk Assessment and Pharmacy-Appropriate Inspection Recommendations. In: Deutsche Apotheker Zeitung. 12/2014.
- ↑ zience.de , accessed on April 12, 2014.
- ↑ Andreas S. Ziegler: Defektur: Risk-based step model and pharmacy-appropriate test methods. Deutscher Apotheker Verlag, 2014, ISBN 978-3-7692-6094-6 .
- ↑ Defectural work aids with risk assessment block. Deutscher Apotheker Verlag, 2014 ISBN 978-3-7692-6308-4 .
