Can pharmacists make new drugs?
The defect lives
The Committee of Ministers of the Council of Europe has issued a resolution on the manufacture of unauthorized medicinal products in pharmacies (Resolution CM / ResAP (2011) 1). In this resolution it is stated that industrially manufactured pharmaceuticals alone cannot cover all individual needs of patients. Therefore, pharmaceuticals produced in pharmacies (unauthorized pharmaceuticals) are an important element of the pharmaceutical supply in Europe.
The resolution demands that the patient can rightly expect to have adequate quality, safety and therapeutic benefit to the same degree regardless of the manufacturing route of a medically prescribed drug. The resolution proposes that the effort for manufacturing documentation and testing for pharmaceuticals manufactured in pharmacies should be structured in a risk-oriented manner. Factors influencing the risk of the drug are, according to the resolution of the Council of Ministers:
Dosage form and route of administration
Potency of the active ingredient
Type of manufacturing process
With a point system, the respective drugs are classified into high or low risk products. This seems reasonable. The resolution expressly emphasizes that each member state can develop its own guidelines that shape this risk classification system, change it and adapt it better to the respective national situation.
Notably, the resolution also advises that the import or export of unauthorized medicinal products should not take place unless there are clear bilateral agreements in place. This is an indication that the dispatch of drugs manufactured in a pharmacy must be rated as a very high risk factor in terms of patient safety, because it extends the usual supply radius of a local pharmacy. In analogy to the statements in the resolution, consideration should be given to restricting this dispatch or significantly increasing the attention of the official monitoring of this distribution channel.
No plausibility check required
Defectiveness drugs are defined in § 1a Paragraph 9 ApBetrO as drugs that are manufactured in advance within the scope of normal pharmacy operations in up to 100 ready-to-sell packs or in a corresponding quantity. The legal regulations on non-prescription drugs can only be understood if one is familiar with the regulations on prescription drugs. In the commentary, defective drugs are described as finished drugs. This also applies if they only have to be bottled in the unchanged form. According to AMG, intermediate products are starting materials. If they are produced for further processing at a later date, they are not covered by the definition in Section 1a (9). In the pharmacy, however, they should also (as before) be counted among the defective drugs and documented in this way.
Examples in everyday pharmacy
In other words: Any manufacture of drugs in pharmacies that does not fall under the regulation of prescription drugs is a defective drug manufacture. From this context it becomes clear that there is no plausibility check for defective drugs. Because either the defective drug is a plausibly checked medical prescription (in larger quantities) or it is based on a standardized prescription formula.
Production in pharmacies is so diverse that only a few examples are listed below:
the filling of five bags of mint tea according to standard approval
a group of alternative practitioners repeatedly prescribed a similar mixture of dilutions, of which the surrounding pharmacies produce between 5 and 200 liters per pharmacy per year, depending on customer frequency.
A pharmacy on the outskirts with two neighboring dental practices provides 15 x 300 ml chlorhexidine digluconate mouthwash 0.2% NRF 7.2 per month. here.
A country pharmacy in a small town with a general practice supplies a dermatological patient with 6 to 8 kg of an ointment with an identical formulation. She makes them three to four times a year on a 2-kg scale.
The pharmacy in a medical center with a large dermatological practice produces 5 kg of a recipe formula that is used over and over again and is given to different patients in different container sizes (20 to 100 g) every other week.
A mail-order pharmacy sends eye drops nationwide according to a formula in which no finished medicinal product is available on the German market. 12,000 pieces are manufactured per year.
In order not to have to use pre-preserved, non-ionic hydrophilic ointment, a pharmacy produces it itself on a weekly basis on a weekly basis.
A pharmacy produces ethanol-water mixtures or formula concentrates.
Testing is usually possible in the pharmacy
The test instructions according to § 8, Paragraph 3 ApBetrO must contain at least information on the sampling, the test method, the type of test and the permissible target and limit values. The drug does not necessarily have to be tested in the pharmacy itself. However, the examination in the pharmacy is often useful and desirable.
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