ACPE UAN: 0475-0000-19-014-L04-P. A knowledge based activity.
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
Inaccessibility to quality medical products is still a neglected issue, whereas current vulnerabilities of the supply chain of the medicines admitted to the market are mapped by several publications. Access is a complex health and development challenge which depends on many factors. Convincing approaches to improve both access to and availability of medicines are scarce. Non-availabilities of essential medicines are recognised as a more and more worsening fact. To evaluate the most promising coping strategies, dependencies from third parties as well as ways to develop an efficient pharmaceutical supply chain of essential medicines should be assessed. Access might be opened by compassionate use and by hospital pharmacy production. Astonishingly, for coping strategies, hospital pharmacy production is not figuring among the highest priorities. However, the revised Swiss Federal Act on Medicinal Products and Medical Devices and its ordinances are taking into consideration the worsening shortages problems and underlines the importance of hospital pharmacy production to cope with shortages and inaccessibilities.
A major factor delaying access that is often overlooked is the marketing authorisation process that may last up to 7 years in some low and lower-middle income countries - from submission to approval of a dossier in one of the listed regulatory authorities, followed by WHO pre-qualification and then from submission to approval in the target countries. Swissmedic, the Swiss Agency for Therapeutic Products has launched an authorisation procedure to tackle this problem: The Swissmedic Marketing Authorisation for Global Health Products (MAGHP) procedure. It is accessible to representatives of regulatory authorities in resource-constrained countries and the WHO. They can follow the MAGHP procedure, provide expert input and gain confidence in its outcome. Through the participation, the timelines for the WHO-PQ listing and marketing authorisation by NMRAs shall be significantly reduced. Overall, this would lead to a faster access to those medicines for the patients in need.
This seminar focuses on options to improve accessibility to medicines and to reduce the hospital pharmacist's dependence on third parties of the supply chain in different settings.
After the seminar, participants should be able to:
• discuss the Swissmedic Marketing Authorisation for Global Health Products (MAGHP) procedure to facilitate of market access;
• consider suitable medicines to be easily prepared in hospital pharmacies;
• assess the feasibility of early access and compassionate use.
Educational need addressed
Drug shortages have been a threatening challenge for hospital pharmacist's mission to supply medicines to patients. Whereas in shortage situations the supply chain is disrupted and medicines not available for a limited time, parts of populations and/or weakest special patient groups suffer from inaccessibility to medicines supply, namely patients with orphan diseases or patients in low- and middle-income countries. These countries further depend on human and financial resources in order to develop an efficient pharmaceutical sufficient supply chain.
Although ethical justification to provide medicines is recognised, it is still unclear how to optimally implement actions to provide essential medicines worldwide to all patient groups.
In this seminar, tools to improve accessibility and availability are described. Hospital pharmacist might assume an ethical and social responsibility to participate in programmes to improve medicine accessibility.
Keywords: (In-)Accessibility to registered medicines, investigational medicines, early accesses (parallel trial, compassionate use), (in-)available (orphan) drugs, shortages, bridging supply chain disruptions by hospital pharmacy production, international relations, bilateral coordination, development coordination, Bill & Melinda Gates Foundation.