Pharmacotherapy of unlicensed medicines prepared and distributed by Dutch pharmacies

Eur J Hosp Pharm. 2018 Nov;25(6):344-348. doi: 10.1136/ejhpharm-2016-001110. Epub 2016 Dec 20.


Introduction and objective: In the Netherlands, preparing and distributing pharmacies (PDPs) are taking over a large proportion of pharmacy preparations. PDPs prepare and distribute medicinal products to dispensing pharmacies. Many pharmacies have stopped pharmacy preparation. However, this contravenes the Dutch Medicines Act and the European Union (EU) Directive 2001/83/EC on which Dutch law is based. This is because the medicinal products of PDPs are unlicensed and PDPs do not have a manufacturing licence.

Methods: To solve the conflict with the Dutch Medicines Act, PDPs have since 2007 been authorised by the Dutch Health Care Inspectorate by means of a circular letter. This circular letter describes the qualitative conditions that must be fulfilled by PDPs. The circular letter's conditions state that PDPs must perform verifiable investigations to assess the availability, or not, of licensed pharmacotherapeutic alternatives (PA investigations) and to assess the pharmacotherapeutic rationale and the needs of the patient (PT investigations).

Results: Regular visits were performed by the Dutch Health Care Inspectorate to check the compliance of PDPs with the circular letter. This article describes the results of these inspections for PA and PT investigations.

Conclusions: The results of the inspections show that so far almost all PDPs inspected have complied with the PA and PT conditions of the circular level at system level. However, in a substantial proportion of cases, the rationale of the pharmacy-made products is insufficient or insufficiently documented.

Keywords: Circular Letter; GMP (Good Manufacturing Practice); PHARMACOTHERAPY; dispensing pharmacy; large-scale preparation through pharmacists; pharmacy preparation; preparing and distrbuting pharmacy; product dossiers.