Linked to EAHP Statements
Section 1 – Introductory Statements and Governance: Statements 1.1, 1.3, 1.6
Section 2 – Selection, Procurement and Distribution: Statements 2.1, 2.2, 2.5, 2.6, 2.7
Section 3 – Production and Compounding: Statements 3.1, 3.2, 3.3, 3.4, 3.5,
Section 4 – Clinical Pharmacy Services: Statements 4.1, 4.2, 4.3, 4.4, 4.8
Section 5 – Patient Safety and Quality Assurance: Statements 5.1, 5.2, 5.3, 5.5, 5.6, 5.11
Section 6 – Education and Research: Statement 6.5
Vulnerabilities of the supply chain are mapped by several publications and cover the most current sources of disruptions. This overview is an important basis for all further considerations of improvement approaches. To evaluate the most promising coping strategies, the criteria to focus on will be to assess the degree of dependencies from third parties. Coping strategies with a low degree of dependences might be the option of choice to improve the availability of vital medicines.
Unavailability is current for new medicines not yet marketed. The availability might be opened by compassionate use and early access.
Astonishingly, for coping strategies, the hospital pharmacy production is not figuring among the most favoured ones. Light is shed on the comparison of identification of worldwide available sources and the quality requirement for hospital pharmacy production, mainly in case of rare orphan drugs.
This seminar focuses on options to reduce the hospital pharmacist's dependence on third parties of the supply chain with a particular evaluation of the traditional hospital pharmacy production.
After the seminar, participants should be able to:
• prepare a list of suitable medicines to be easily prepared in hospital pharmacies;
• assess the feasibility of early access;
• find orphan drug providers.
Educational need addressed
Drug shortages have been an emerging and more and more threatening challenge for the hospital pharmacists mission to supply medicines to patients. All medicines groups are concerned by non-availabilities. Often, the weakest patient groups are suffering from non-availabilities, namely patients with orphan diseases or patients being treated with medicines of low return on investments for the producers.
Whereas non-availabilities of vital medicines are recognised as a fact, approaches to improve the availabilities fail due to never ending dependencies on third parties such as producers of APIs and of products, as well as pre-wholesalers and wholesalers. Hospital pharmacist have to apply coping strategies promising in independence of third parties.
Keywords: orphan drugs, shortages, parallel trial, compassionate use, early access