27th EAHP Congress - PRE-Evaluation and Learning Assessment Form

SPD2 - The shortage pandemic – why we haven’t succeeded yet

Speaker: Joao Ferreira

ACPE UAN: 0475-0000-23-012-L04-P - A knowledge-based activity

The European Association of Hospital Pharmacists (EAHP) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
More information: https://www.eahp.eu/congresses/acpe

Self-assessment questions:

Question Title

* 1. Regulatory authorities - within and outside Europe - are increasingly working together to prevent shortages and to limit their impact whenever they occur. In December 2016, a joint HMA/EMA Task Force on the Availability of Authorised Medicines for Human and Veterinary Use (TF-AAM) was established to provide strategic support and advice to tackle disruptions in the supply of human and veterinary medicines and ensure their continued availability.

True

False

Other (please specify)

Question Title

* 2. Regulation (EU) 2022/123 aimed to empower the EU to react to health crises quickly, efficiently, and in a coordinated manner. It formalised some of the structures and processes EMA set up during the COVID-19 pandemic and assigned new tasks to the European Medicines Agency (EMA) in monitoring and mitigating potential or actual shortages of critical medicinal products, medical devices and in-vitro diagnostics for human use.

True

False

Other (please specify)

Question Title

* 3. The role of the European Medicines Agency's (EMA) Executive Steering Group on Shortages and Safety of Medicinal Products is to ensure a robust response to medicine supply issues caused by major events or public health emergencies. The MSSG's responsibilities include monitoring the supply and demand for critical medicines during public health emergencies (e.g. COVID-19, Mpox).

True

False

Other (please specify)

SPD2 - The shortage pandemic – why we haven’t succeeded yet

Link to EAHP Statements
Section 2 - Selection, Procurement and Distribution: Statements - 2.2, 2.5, 2.6

ACPE UAN: 0475-0000-23-012-L04-P - A knowledge-based activity

Abstract
After many years the occurrence of medicines shortages still constitutes a steady challenge for hospital pharmacists in terms of various shortages’ management aspects. For example, when it comes to suggesting and sourcing therapeutic alternatives and accompanying the transition of medicines in various setting with expertise, information and education. If applied mitigation strategies fail, this challenge expands and escalates to other healthcare professionals and patients. The availability of therapeutically equivalent therapeutic options is considered a best-case scenario, whereas lack of adequate alternatives and resulting consequences (e.g. therapeutic delays) can be seen as a worst-case scenario.

In the past years, several different initiatives and projects, involving different stakeholders and other parties, were established, investigating causes and developing counteracting measures. Research on medicines shortages is conducted, as illustrated by many publications on various management aspects. On a political level, the problem of shortages is accepted as an essential and important one.

In 2020, the COVID-19 pandemic dramatically proved how fragile and susceptible supply chains of medicines still are and how quickly apparently stable situations can aggravate. After all achievements in the context of medicines shortages’ management prior to COVID-19, enormous efforts are still needed to counteract shortages and stabilise drug supply sustainably. Is it realistic to consider shortages an unsolvable problem? Did shortages come to stay?

Learning objectives
After the session, the participant should be able to:

Repeat key facts about current epidemiology and aetiology of medicines shortages
Recall up-to-date and actual initiatives on an European and global level to address shortages and discuss various strategies against it
State key learnings from the COVID-19 pandemic in the context of shortages management, both on a practice and political level

Educational need addressed
Hospital pharmacists are responsible for providing the right medicines to patients and therefore essentially rely on trusted availability of medicines. Extensive state-of-the-art knowledge on medicines shortages and all relating activities is key to fulfil this core responsibility of hospital pharmacy.

Keywords: Medicines shortages, pandemic, counteracting strategies