In order to register a hospital pharmacy, the pharmacist in charge must provide specific information to the FAGG, including their name, national register number, and hospital approval number. They also need to submit a plan showing the pharmacy’s layout. If more than one pharmacist is responsible, details of each must be included. Additionally, a pharmacist must declare their responsibility according to healthcare regulations.
Changes to registration details must be reported within sixty days. If responsibilities change or the pharmacy ceases operation, prompt notification is required. The FAGG can delete registrations under certain conditions, such as prolonged inactivity or lack of responsible personnel.
Requests for registration must be sent via registered mail, with electronic submission being a potential option. The FAGG verifies applications within fifteen working days. If complete, registration occurs within ten days. Incomplete applications must be rectified within thirty calendar days. Once registered, a certificate is issued, which must be kept on-site and presented upon request.
Registration details are made public by the FAGG on its website.
“Only hospital pharmacists can dispense medicines within the institution. They review prescriptions for accuracy and may substitute medicines unless instructed otherwise by the prescriber. If needed, they adjust doses according to legal standards”
Individualised drug distribution involves dispensing medicines according to specific prescriptions or standing orders, ideally in unit packaging. The pharmacist ensures packages cover no more than a seven-day treatment period.
Emergency cabinets, overseen by the pharmacist, contain medicines and devices for urgent situations. Their contents are determined in consultation with relevant medical staff and must comply with pharmacy practice guidelines. Cabinets are regularly checked and restocked, with access restricted to authorised personnel.
Emergency situations include immediate treatment needs, prescriptions outside regular hours, or unpredictable medical demands in critical hospital areas.
Article 14 outlines the required information on pharmacy preparations’ packaging, including composition, form, preparation date, administration method, expiry date, storage conditions, patient details (for masterful preparations), and hospital details.
Chapter IV details procedures for cleanliness, hygiene, and maintenance in the hospital pharmacy to prevent product contamination.
Article 16 mandates the availability of medicines, medical devices, and therapeutic formularies in the hospital pharmacy at all times.
Articles 17 to 23 discuss regulations for pharmacy preparations, sterilisation, unit packaging, and outsourcing.
Chapter V covers specific provisions for product storage, disposal, and closure procedures.
Chapter VI details data registration requirements for medicines, medical devices, and patient administration regimens.
For a continuous period of ten years, the hospital pharmacist is required to maintain records, either electronically or in writing, to ensure the traceability of medicines and medical devices in the hospital pharmacy. These records must include the following details for each compounding:
- Date of compounding
- Name and pharmaceutical form of the medicine
- Quantity entered in stock
- Name and address of the supplier
- Lot number or serial number
Trade documents can also serve as part of these records to fulfil this requirement. These measures are essential to track the procurement and usage of medicines and medical devices, ensuring transparency and compliance with regulatory standards.