Linked to EAHP Statements:
Section 3 - Production and compounding: Statements 3.1, 3.2, 3.3, 3.4, 3.5, 3.6
Section 4 - Clinical pharmacy services: Statements 4.6, 4.7
Section 5 - Patients safety and quality assurance: Statements 5.2, 5.11
Section 6 - Education and research: Statement 6.4
Pharmacy preparation is the art and science of preparing personalized medications for patients. Pharmacy prepared medications are made based on a practitioners prescription in which individual ingredients are mixed together in the exact strength and dosage form required by the patient. This method allows the pharmacist to work with the patient and the prescriber to customize a medication to meet the patient's specific needs. Extemporaneously prepared medicines (also known as extemporaneous preparations, compounded preparations, pharmacy preparations) are unlicensed medicines and have not generally been assessed for safety and efficacy.
Extemporaneously prepared medicines are used in paediatric, geriatric, and special needs patients. Special prepared dosage forms like RTA's (Ready To Administer) improve safety. New technical developments are coming into practice and require knowledge of e.g. ATMP's (Advanced Therapy Medicinal Products). From time to time pharmacy preparations also may play a role in case of shortages.
Pharmacy preparation is a unique competency reserved to pharmacists within healthcare establishments. According to the European law preparation is restricted to own patients of a pharmacy. However, in some European countries delivery between pharmacies is allowed.
Norms established by the Council of Europe for quality assurance and safety of medicines prepared by pharmacies specialised in preparation have been enshrined in Resolution CM/Res(2016)1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients (Succeeding Resolution CM/ResAP(2011)1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients). The resolution is major breakthrough in protecting patient safety and in preventing gaps in quality and safety between medicinal products prepared in pharmacies and those made in industrial setting. National legislation should be adapted in accordance with the resolution.
After the seminar, participants should be able to:
- understand regulatory framework of pharmaceutical preparations and actual developments of legislation in Europe;
- provide rationales and examples of pharmacy preparations for paediatric, geriatric, and special needs patients used in present hospital and ambulatory practice;
- identify and manage clinical and technical risks of patients requiring an extemporaneously prepared medicines;
- anticipate future developments and areas of research and education in pharmacy preparations in hospital and ambulatory practice.
Educational need addressed
Extemporaneously prepared medicines (pharmacy preparations) are still an integral part of hospital pharmacist profession. Hospital pharmacist must be aware of legal environment and legal consequences of extemporaneously prepared medicines, present and future trends in extemporaneous compounding, understand how to miniminize potential risks to patients, healthcare staff and their organisation.
Keywords: extemporaneous preparation, pharmacy preparations, risk management, resolution CM/Res(2016)1.