Semi-industriele bereidingen in de apotheek

Stricter requirements on the therapeutic benefit, labelling and manufacturing processes should be set for drug products manufactured by pharmacies on a semi-industrial scale. In the Netherlands only drug products authorized by the Dutch Medicines Evaluation Board or the European Medicines Agency may be sold. In exceptional cases, pharmacies are allowed to manufacture drug products for their own patients. As the volume of manufacturing by pharmacies is decreasing, along with the availability of sufficient experience and suitable equipment in the pharmacies themselves, more and more pharmacies are now turning to dispensing drug products that have been manufactured in other pharmacies, often manufactured on larger scales than is usual for pharmacies. This type of manufacturing by certain pharmacies clearly supplies a need, especially for drug products requiring more complicated manufacturing processes. Exploratory research has demonstrated that the chemical-pharmaceutical quality of 32 drug products examined complied, in general, with the requirements. However, the labelling was often incomplete, and there was a lack of administrative discipline; furthermore, the therapeutic benefit of about half of these drug products proved questionable. For some products, pharmacy drug manufacturing seemed to be used to market products of questionable benefit without the approval of the Medicines Evaluation Board or the European Medicines Agency. In view of the observed batch sizes and the associated larger risks, one needs to consider whether drug product manufacturing by pharmacies on semi-industrial scale should also meet the same requirements for the manufacturing of approved products. According to the EU Directive 2001/83/EC, drug product manufacturing in pharmacies is only allowed on a small scale. This directive is now being implemented in a new Dutch medicines law. To allow manufacture on semi-industrial scale in pharmacies in future, a provision in or additional to the new Dutch law needs to be introduced