Do you have a pharmacy in your hospital? Then you need to respect the Royal Decree relating to the preparation and delivery of medicines and the use and distribution of medical devices within care facilities. Here’s a helpful overview with the most important topics:
The decree of 30 September 2020 enforces some general rules that must be applied in the case of pharmaceutical preparations:
– As a hospital pharmacy, you must establish procedures for cleanliness, hygiene, temperature, disinfection and ventilation of the premises.
– Procedures must be in place to ensure proper maintenance and functioning of instruments and installations.
– Hospital pharmacies are obliged to keep an electronic register, recording the following information: medicinal products / preparations delivered, date of delivery, identification of prescriber – patient and product, delivered quantity, lot number. A yearly electronic overview of all medicinal products and raw materials plus the quantities in stock should be signed and dated by the hospital pharmacist and kept available for the Federal Agency of Medicines and Health Products.
– You are also obliged to implement an electronic administration schedule per patient for all medicinal products and medical devices to be used by patients during their stay in the healthcare facility.
– 1 January 2023 is the deadline to implement the Pharmaceutical Inspection Co-operation Scheme (PIC/s) Guide to good practices for the preparation of medicinal products in healthcare establishments (Annex III to this Royal Decree). This guide describes the preparation of medicinal products performed by healthcare facilities for direct supply to patients. It is divided into 9 chapters, according to the same structure as the GMP Guide of industry (PIC/S document PE 009): Quality Assurance System, Personnel, Premises & Equipment, Documentation, Production, Quality Control, Outsourced activities, Complaints & Product Recalls, Self-inspections.
All documents discussed in this Royal Decree must be kept for at least 10 years, for traceability purposes. When it comes to medicinal products and medical devices, the following information must be retained: date of purchase, name and pharmaceutical form, purchased quantity, name and address of the supplier, batch number or serial number.
As a hospital, you may also outsource certain activities if you wish, such as the preparation of magistral preparations, sterilization of medical devices or preparation of unit packages. If you do, don’t forget to ensure a quality agreement is in place between both parties.
In addition to general rules, the Royal Decree also describes good practice for hospital pharmacies. In Annex 1 you can find details of:
Q-support can guide hospital pharmacies in implementing the new Royal Decree and will be happy to assist you in setting up and/or managing an appropriate Quality Management System.
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